510(k) · Cleared
ClearedOzark (tm) Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 23, 2017 as substantially equivalent to K152281 (K2m, 2015) and 4 other predicates after a 42-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it.
- Decided
- Aug 23, 2017
- Review
- 42 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K971730 (1997). 39 ancestors in all, the oldest K792352 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 5 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- 4 generations backK042317 Cervical PlateScient'X · 2004
- 3 generations backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
- 2 generations backK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- 1 generation backK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
- This deviceK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 2 generations on · 1 of its ownK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · cites it directly4descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · cites it directly1descendant
- K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation · 2022 · 2 generations on1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 2 generations on0descendants
- K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −5 | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| −4 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| −3 | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | 1 |
| −2 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| −1 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
| 0 (this device) | K172104 | Ozark (tm) Cervical Plate System | K2m, Inc. | 2017 | — |
| +1 | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK… | K2m, Inc. | 2018 | — |
| +1 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +2 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
| +2 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
| +3 | K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical… | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152281 | Pyrenees Cervical Plate SystemSummary page 5…ts are manufactured from titanium alloy as described by ASTM F136 and ASTM F1472. Primary Predicate: Pyrenees Cervical Plate System (K2M – K152281) Additional Predicates: Additional: Zavation Cervical Plate System (Zavation LLC – K130030), SKYLINE®… | 2015 |
| * | K130030 | Zavation Cervical Plate SystemSummary page 5…d ASTM F1472. Primary Predicate: Pyrenees Cervical Plate System (K2M – K152281) Additional Predicates: Additional: Zavation Cervical Plate System (Zavation LLC – K130030), SKYLINE® Anterior Cervical Plate System (DePuy Spine Inc. – K103491, VueLock®… | 2013 |
| * | K103491 | Skyline Anterior Cervical Plate SystemSummary page 5…l Predicates: Additional: Zavation Cervical Plate System (Zavation LLC – K130030), SKYLINE® Anterior Cervical Plate System (DePuy Spine Inc. – K103491, VueLock® Anterior Cervical Plate System (Biomet Spine [nee EBI] – K023133), Ce… | 2011 |
| * | K023133 | Modification to Ebi Vuelock Anterior Cervical Plate SystemSummary page 5…or Cervical Plate System (DePuy Spine Inc. – K103491, VueLock® Anterior Cervical Plate System (Biomet Spine [nee EBI] – K023133), Cervical Spine Locking Plate (CSLP) (Synthes Spine – K030866) Performance Data: Mechanical testing of the Ozark Cervical… | 2002 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 5…VueLock® Anterior Cervical Plate System (Biomet Spine [nee EBI] – K023133), Cervical Spine Locking Plate (CSLP) (Synthes Spine – K030866) Performance Data: Mechanical testing of the Ozark Cervical Plate System constructs was performed… | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 8 of the 39 ancestors have a recall of any class.
- Of its descendants, K182473 (K2m, Inc., 2018) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172104: Ozark (tm) Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172104
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026